Drug License

A drug license is a legal permit issued by health authorities for manufacturing, distributing, or selling pharmaceutical products. It ensures compliance with quality, safety, and regulatory standards. Obtaining a drug license is mandatory to operate in the pharmaceutical industry.

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    • Total payment may vary depending on government fees and the entity of the company.
    • Downtime on the government portal may cause work delays.
    • Documents should be appropriate as per the requirements.
    • Documents must be provided in time to avoid delay.
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A Drug License, also known as a pharmaceutical license or a drug selling license, is a legal permit issued by the respective state's drug control authority or the Central Drugs Standard Control Organization (CDSCO) for the sale, distribution, or manufacturing of drugs and pharmaceutical products. It is mandatory for individuals or entities involved in the sale, distribution, or manufacturing of drugs, including pharmacies, wholesalers, retailers, and drug manufacturers.

Drug Licenses are categorized into various types based on the nature of the activity and the scale of operation. These include Retail Drug License (for pharmacies and retailers), Wholesale Drug License (for wholesalers), Manufacturing Drug License (for drug manufacturers), and Loan License (for contract manufacturing under a manufacturing licensee).

Holders of Drug Licenses are responsible for ensuring compliance with applicable laws, regulations, and quality standards related to the sale, distribution, or manufacturing of drugs. They are required to maintain accurate records of inventory, sales, and transactions, ensure the safety, efficacy, and quality of drugs, and report adverse events or incidents as per regulatory requirements.

Operating without a valid Drug License is illegal and may lead to severe consequences, including penalties, fines, suspension or revocation of the license, closure of the establishment, and legal actions by drug authorities. Additionally, unauthorized sale or distribution of drugs poses risks to public health and safety and undermines consumer trust in the healthcare system.